BEUDAMED
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    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·July 15, 2015

    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Recall
    Terminated ·3M Company Health Care Business 3M Center·Product code EBF·June 15, 2015

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)

    FDA Enforcement
    Class II ·Terminated·LW Scientific, Inc.·April 3, 2019

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

    FDA Enforcement
    Class II ·Terminated·LW Scientific, Inc.·April 3, 2019

    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes

    FDA Enforcement
    Class II ·Terminated·LW Scientific, Inc.·April 3, 2019

    6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code HWX·April 13, 2012

    4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010

    AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, AADCO Medical, Inc., Randolph, VT. 05060

    FDA Recall
    Terminated ·Aadco Medical Inc.·Product code IWX·November 1, 2007

    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.

    FDA Recall
    Terminated ·Zimmer Spine, Inc.·Product code HWX·May 21, 2004

    8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code HWX·May 3, 2013

    7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code HWX·April 21, 2010

    Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code HWX·August 8, 2008

    CBS 7.5 tap, cannulated, AO, Item Number 503002041

    FDA Recall
    Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWX·April 8, 2019

    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010